Responsible for preparation and submission of DMFs, LOA and CEP certification for USFDA, EDQM, China, Japan, Taiwan, Singapore, Russia, Pic(s) members and ROW market. Exposure of eCTD submissions and filing of changes by Lorenz software, submission through USFDA gateway, CESP gateway and to other authorities. Exposure of preparation of Nitrosamine and Genotoxic Risk assessment Reports. Also responsible for handling queries from various Regulatory Authorities as well as from customers and various day to day practices like data management as well as documents management.